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Human Wound and Its Burden: Updated 2022 Compendium of Estimates.

Significance: Chronic wounds affect 10.5 million (up 2.3 million from the 2014 update) of U.S. Medicare beneficiaries. Chronic wounds impact the quality of life of nearly 2.5% of the total population of the United States. This fraction is larger in the elderly. These wounds can lead to a range of complications and health care costs. Given the aging population, the continued threat of diabetes and obesity worldwide, and the persistent problem of infection, it is expected that chronic wounds will continue to be a substantial clinical, social, and economic challenge. Disparities in the prevalence and management of chronic wounds exist, with underserved communities and marginalized populations often facing greater challenges in accessing quality wound care. These disparities exacerbate the public health burden. Recent Advances: U.S. Centers for Medicare and Medicaid Services had proposed revision of its local coverage determination limiting the use of skin substitute grafts/cellular and/or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers in the U.S. Medicare population. In response to the comment phase, this proposal has been put on hold. The U.S. Food and Drug Administration (FDA) has renewed its focus on addressing nonhealing chronic wounds and has outlined efforts to address identified barriers to product development for nonhealing chronic wounds. The new approach places emphasis on engaging key wound healing stakeholders, including academia, professional associations, patient groups, reimbursement organizations, and industry. Finally, recent advances demonstrating that wounds closed by current FDA definition of wound closure may remain functionally open because of deficiencies in restoration of barrier function warrant revisiting the wound closure endpoint. Such "closed" wounds that are functionally open, also known as invisible wounds, are likely to be associated with high wound recurrence. Future Directions: Addressing the public health problem of chronic wounds will require a multifaceted approach that includes prevention, improved wound care management, and addressing the underlying risk factors.

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